Clinical trials: Safety Study
Herpes Zoster
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in subjects' ≥ 50 years of age (YOA) who previously have had Herpes Zoster (HZ).
- Trial name
- NCT01827839
- Testing
- Herpes Zoster vaccine (GSK1437173A)
- Where
- 4 sites in Canada, Russia
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus (T2DM)
A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.
- Trial name
- NCT05761301
- Testing
- ALN-KHK
- Where
- 15 sites in United States, Canada
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Healthy
Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males
The main purpose of this study is to assess the safety, tolerability, and biological activity of SD-101 compared with placebo in healthy male volunteers.
- Trial name
- NCT00599001
- Testing
- SD-101
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Respiratory Syncytial Virus Infections
RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo.
- Trial name
- NCT02864628
- Testing
- MVA-BN-RSV
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Healthy Volunteers
Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants
This is a randomized, double-blind, placebo-controlled, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses…
- Trial name
- NCT07787611
- Testing
- MWN109 tablet
- Where
- China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Shanghai Minwei Biotechnology Co., Ltd
Dengue Fever
Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity
This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous (SC) or intramuscular (IM) administration with…
- Trial name
- NCT01728792
- Testing
- TDV
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Takeda
Pulmonary Fibrosis, Tumor
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
This is a first-in-human, single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.
- Trial name
- NCT05740475
- Testing
- 9MW3811 injection
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Major Depressive Disorder, Recurrent, Unspecified
Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005
Objectives To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in healthy subjects. To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.
- Trial name
- NCT02271412
- Testing
- LY03005
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Healthy
Evaluation of Dose-effect of a New Fermented Food in Healthy Adults
The aim of the study is to assess the safety and tolerance of a new fermented food versus a control product in healthy adults during the 4-week consumption period.
- Trial name
- NCT01108419
- Testing
- Fermented dairy product, milk-based non-fermented dairy product
- Where
- Germany
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center
Healthy Volunteers
A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers
This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.
- Trial name
- NCT02873767
- Testing
- PR1, PL1
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Cough
The Safety, Tolerability, PK and PD of GSK2339345 in Healthy Subjects
This is a First Time in Human (FTIH) study for the sodium channel inhibitor, GSK2339345. The study is split into two parts. Part A will assess the safety and tolerability of the new drug.
- Trial name
- FTIH (NCT01494636)
- Testing
- GSK2339345 (solution), GSK2339345 (nebulised), Lidocaine
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Ovarian Cancer, Healthy Volunteers
Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients
Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian…
- Trial name
- NCT01689636
- Testing
- Tc 99m EC20
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Endocyte
Healthy
To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers
1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions 2.
- Trial name
- NCT05433844
- Testing
- Reference Drug or Test Drug
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- JW Pharmaceutical
Clostridium Infections
Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years
The purpose of this study is to generate safety, reactogenicity (assessment of any expected or unexpected side effect of the vaccine) and immunogenicity (ability to induce an immune response) data for the development of a…
- Trial name
- NCT04026009
- Testing
- C. difficile investigational vaccine based on the F2 antigen (GSK2904545A), C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
COVID-19
Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine
This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety…
- Trial name
- COVID-19-101 (NCT04497298)
- Testing
- Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low dose, Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High dose, One COVID-19 vaccine candidate (TMV-083/V-591) administration - High dose
- Where
- 2 sites in Belgium, France
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Influenza
Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)
This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older…
- Trial name
- NCT03293498
- Testing
- NanoFlu, Fluzone HD - Day 0, Fluzone HD - Day 21
- Where
- 3 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Novavax
Atopic Dermatitis
A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B)
The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants…
- Trial name
- NCT05277571
- Testing
- UCB1381
- Where
- 16 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Healthy Volunteers
A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016
This is a single dose-escalation phase Ⅰa clinical study to observe the safety and pharmacokinetic profiles of RBD1016 in healthy subjects.
- Trial name
- NCT04685564
- Testing
- RBD1016
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Suzhou Ribo Life Science Co. Ltd.
Healthy Male Volunteers
Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs
drug-drug interaction between DWP14012 and three different kinds of NSAIDs
- Trial name
- NCT04490434
- Testing
- DWP14012, Celecoxib, Naproxen
- Where
- South Korea
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Frailty
A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty
The goal of this phase I/II clinical trial is to evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in patients with aging frailty.
- Trial name
- NCT06070532
- Testing
- Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)
- Where
- The Bahamas
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cellcolabs Clinical LTD.
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